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This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Anonymized data of patients treated with brolucizumab intravitreal injection (IVI) who had received the first dose of brolucizumab between 01 October 2020 and 31 March 2021 was collected. Patients could either be treatment-naïve or previously treated with single or a combination of other IVI of anti-vascular endothelial growth factors (VEGFs). The primary outcome measure was the change in fluid levels (intra-retinal fluid [IRF], sub-retinal fluid [SRF], and pigment epithelial detachment [PED]) from baseline to Month 3. Secondary outcome measures included change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), number of brolucizumab injections, and safety (number of adverse events [AEs]). Descriptive statistics were tabulated for the demographic and clinical characteristics as well as outcome variables.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline | Percentage of patients with either absence of intra-retinal fluid (IRF) at Month 3 or a reduction of IRF at Month 3 compared to baseline. | From baseline to Month 3 |
| Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline | Percentage of patients with either absence of sub-retinal fluid (SRF) at Month 3 or a reduction of SRF at Month 3 compared to baseline. | From baseline to Month 3 |
| Percentage of patients with absence or reduction of PED at Month 3 compared to baseline | Percentage of patients with either absence of pigment epithelial detachment (PED) at Month 3 or a reduction of PED at Month 3 compared to baseline. | From baseline to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR) | Baseline and Month 3 | |
| Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline | Baseline, Months 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
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This was a retrospective, noninterventional cohort study
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narayana Nethralaya | Bangalore | India | ||||
| Disha Eye Hospital |
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| Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline | Baseline, Months 1 and 2 |
| Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline | Baseline, Months 1 and 2 |
| Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT) | Baseline, Months 1, 2, and 3 |
| Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment | Months 1, 2, and 3 |
| Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment | Months 1, 2, and 3 |
| Number of visits during Months 1, 2, and 3 of brolucizumab treatment | Months 1, 2, and 3 |
| Number of patients with treatment-emergent adverse events | Baseline to Month 3 |
| Kolkata |
| India |
| Susrut Eye Foundation and Research Center | Kolkata | India |
| Dr. Milan's Retina Care Center | Rajkot | India |